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U.S. Department of Health and Human Services

Class 2 Device Recall TX1 Tissue Removal System

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  Class 2 Device Recall TX1 Tissue Removal System see related information
Date Initiated by Firm March 30, 2013
Date Posted June 06, 2013
Recall Status1 Terminated 3 on March 24, 2014
Recall Number Z-1516-2013
Recall Event ID 65113
510(K)Number K101561  
Product Classification Instrument, ultrasonic surgical - Product Code LFL
Product American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.



Code Information Serial#: 5510124 55400000 55400001 55400002 55400003 55400004 55400005 55400006 55400007 55400008 55400009 55400010 55400011 55400012 55400013 55400014 55400015 55400016 55400017 55400018 55400019 55400020 55400021 55400022 55400023 55400024 55400025 55400026 55400027 55400028 55400029 55400030 55400031 55400032 55400033 55400034 55400035 55400036 55400037 55400038 55400039 55400040 55400041 55400042 55400043 55400044 55400045 55400046 55400047 55400048 55400049 55400050 55400051 55400052 55400053 55400054 55400055 55400056 55400057 55400058 55400059 55400060 55400061 55400062 55400063 55400064 55400065 55400066 55400067 55400068 55400069 55400070 55400071 55400072 55400073 55400074 55400075 55400076 55400077 55400078 55400079 55400080 55400081 55400082 55400083 55400084 55400085 55400086 55400087 55400088 55400089 55400090 55400091 55400092 55400093 55400094 55400095 55400096 55400097 55400098 55400099 55400100 55400101 55400102 55400103 55400104 55400105 55400106 55400107 55400108 55400109 55400110 55400111 55400112 55400113 55400114 55400115 55400116 55400117 55400118 55400119 55400120 55400121 55400122 55400123 55400124 55400125 55400126 55400127 55400128 55400129 55400130 55400131 55400132 55400133 55400134 55400135 55400136 55400137 55400138 55400139 55400140 55400141 55400142 55400143 55400144 55400145 55400146 55400147 55400148 55400149 55400150 55400151 55400152 55400153 55400154 55400155 55400156 55400157 55400158 55400159 55400160 55400161 55400162 55400163 55400164 55400165 55400166 55400167 55400168 55400169 55400170 55400171 55400172 55400173 55400174 55400175 55400176 55400177 55400178 55400179 55400180 55400181 55400182 55400183 55400184 55400185 55400186 55400187 55400188 55400189 55400190 55400191 55400192 55400193 55400194 55400195 55400196 55400197 55400198 55400199 55400200 55400201 55400202 55400203 55400204 
Recalling Firm/
Manufacturer		 American Optisurgical Inc
26902 Vista Ter
Lake Forest CA 92630-8123
For Additional Information Contact
949-580-1266
Manufacturer Reason
for Recall		 The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo
FDA Determined
Cause 2		 Device Design
Action "Urgent Medical Device Recall" notifications letters were sent to customers on May 20, 2013 via USPS registered mail. Included in the Recall Notification Letter were the recommended actions and instructions for customers. Questions were referred to (949) 580-1266.
Quantity in Commerce 194 units
Distribution Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LFL and Original Applicant = AMERICAN OPTISURGICAL, INC.
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